Obesity Clinical Trial
Official title:
Nutrition and Exercise Study to Understand Metabolic Syndrome
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone.
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week
yoga program coupled to health education (HED) compared to HED alone. In a randomized
clinical trial of 90 patients (45 patients per arm), investigators will measure the effects
of the two interventions on IR, HTN, dysplidemia, and body composition (See Figure 1. Study
Diagram). Subjects will be scheduled for outcome assessment at baseline, 12 weeks, and 24
weeks. In addition, investigators will collect data at baseline and 12 weeks on
self-efficacy, stress, mindfulness, and mood. As a sub-study to the randomized controlled
trial, investigators will measure the aerobic intensity of the yoga to estimate the dose of
physical exercise provided by the yoga (n=10).
Subjects willing and eligible to participate in the RCT will receive written consent.
Consented subjects will be randomized to either 12 weeks of yoga with HED versus HED alone.
Subjects randomized to yoga will receive 30 to 45 minutes of weekly yoga instruction,
followed by 30 to 45 minutes of HED. Subjects will receive written instructions for home
yoga practice and lifestyle changes based on HED. Subjects randomized to HED alone will
receive a weekly standardized HED curriculum which will be attention and time matched to the
yoga with HED arm.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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